THURSDAY, June 9 (HealthDay News) -- The U.S. Food and Drug
Administration is calling for new warning labels on a class of
drugs used primarily to treat enlarged prostates, because the
medications may raise the risk of developing an aggressive form of
In a statement released Thursday, the agency said the drugs
involved include popular medications sold under the brand names
Proscar and Propecia (sold by Merck & Co.) and Avodart and
Jalyn (sold by GlaxoSmithKline).
According to the FDA, almost 5 million men were prescribed one
of these medications between 2002 and 2009. Of these, nearly 3
million men were between the ages of 50 and 79.
The agency is advising doctors not to start patients on these
drugs until prostate cancer -- which can mimic the symptoms of an
enlarged prostate -- and other urological conditions have been
According to the agency, this new warning is based on the
results of two large prostate cancer trials.
Although these trials did not include Propecia, which is
prescribed to treat hair loss in men, its label is also being
updated. However, the FDA said "the applicability of the Avodart
and Proscar studies to Propecia, is currently unknown."
All of these drugs are part of a class of medications called
5-alpha reductase inhibitors (5-ARI). According to the FDA,
Proscar, Avodart and Jalyn are approved to treat symptoms of
enlarged prostate, while Proscar and Avodart are also approved to
reduce the risk of urinary retention or surgery related to an
enlarged prostate. Propecia is a lower-dose version of Proscar.
Merck issued a statement Thursday on the FDA ruling.
"Merck stands behind the demonstrated safety and efficacy of Proscar [finasteride, 5mg] and Propecia [finasteride, 1mg]. Both products have been prescribed to millions of men, with Proscar prescribed to those suffering from benign prostatic hyperplasia (BPH or enlarged prostate) since 1992, and Propecia prescribed to men with male pattern hair loss since 1997," the company statement said. "Merck's goal is to ensure the product labeling includes all relevant trial information to help health-care professionals and their patients make informed treatment decisions."
Less than a year ago, GlaxoSmithKline asked the FDA to approve
the use of Avodart to prevent prostate cancer, although the FDA
declined that request in January. The company based its reasoning
on the results of one of the trials on which the agency is now
basing its new warning.
In addition to this new side effect, recent research has shown
that Proscar, Propecia and Avodart are all associated with
increasing the risk of erectile dysfunction in men who take the
Commenting on the FDA warning, prostate cancer expert Dr.
Anthony D'Amico, chief of genitourinary radiation oncology at
Brigham and Women's Hospital in Boston, said, "I think that the
warning is appropriate. The risk is very small, but not zero."
"What both studies show conclusively is there is about a 1 percent increase in being diagnosed with high-grade prostate cancer if you got these drugs -- even though you are less likely to get a low-grade cancer."
Why that is is not clear, D'Amico said. "But I think the warning
is fair," he added.
The drugs really do work in preventing prostate cancer, D'Amico
said. "You have to weigh the 24 percent reduction against the 1
percent increased incidence of high-grade disease," he said.
"These drugs should only be used in men who have an additional indication to take them beyond prostate cancer prevention," D'Amico said.
For more on prostate cancer, visit the
American Cancer Society.
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